1. Field of the Disclosure
The present invention relates to a container for storing and/or applying a substance, comprising a glass body enclosing a cavity and having a distal end with a first opening, and one or more connecting elements which are attached to the glass body and are made of or comprise a plastic material, wherein one of the connecting elements is disposed at the distal end. As an example of substances that can be stored in the container according to the invention pasty, liquid as well as gaseous substances and mixtures and dispersions and emulsions may be mentioned. Since glass is highly inert against a majority of common chemicals and pharmaceutical substances and has a high diffusion resistance, it is particularly suitable for storing pharmaceutical substances. Due to the high diffusion resistance permeation losses during storage are low, which is in particular an essential aspect for high-quality pharmaceutical substances.
2. Description of Related Art
Particularly in modern pharmaceutical substances that are very expensive, highly effective and very sensitive, there is a growing tendency to use pre-filled syringes or carpules, wherein for the reasons mentioned above glass syringes are suited. With pre-filled syringes it is no longer necessary to transfer the substance from one container into another container. Rather, the pre-filled syringe is ready for use immediately after unpacking. Apart from saving time for the doctor or the nurse there is an additional advantage in that losses are avoided that frequently occur during the transfer from one container to the other. In addition, during the transfer there is a risk of infection or contamination of the substance and/or the syringe. This risk is considerably reduced with pre-filled syringes.
Typically syringes have a thin channel at the place where the needle is connected. In the case of glass syringes this thin channel is formed by use of a tungsten pin which serves as a forming tool during the forming process. The heated glass is pressed onto the exterior surface of the tungsten pin in the region of the channel. After completion of the forming process the tungsten pin is removed from the syringe and the channel remains.
Without the use of the tungsten pin the thin channel cannot be manufactured with the desired accuracy. In addition, there is a risk that the channel will be closed without the use of the tungsten pin during the forming process. Thus, the pin is made of tungsten because it is able to withstand the high temperatures to which the glass has to be brought during the forming process in order to achieve the required viscosity without substantial chemical or mechanical changes. Here, however, it is disadvantageous that abrasion occurs when the tungsten pin is removed so that tungsten residues remain within the syringe which can migrate into the stored substance. This is particularly undesirable when pharmaceutical substances are stored in the syringe.
In addition, syringes have relative complicated geometries in order to be able to connect cannulas or tubings for the application of the pharmaceutical substances. As an example, at this point a Luer-Lock connector may be mentioned, which can be manufactured only with considerable effort from glass and is not suitable for a mass production by use with glass. For these reasons there is a tendency to use pre-filled syringes made of plastic, whereby it is possible to produce even more complex geometries with relative little effort, for example by means of an injection molding process. However, the molding tools for manufacturing plastic syringes are relative complex, such that the production of plastic syringes is usually profitable only for large quantities. In addition, a separate molding tool must be provided for each syringe size. However, plastic materials have not nearly the same inert properties as glass, so that only a limited number of pharmaceutical substances can be stored in plastic syringes. In addition, the shelf life of pharmaceutical substances in plastic syringes is lower than that of glass syringes due to the lower diffusion resistance. Moreover, considerable permeation losses occur during storage. These permeation losses can be reduced by special coatings, which, however, are complicated to produce.
US 2010/0280414 A1 on the one hand discloses a container for storing a biological sample such as blood, which is closed with a plug-shaped connecting element, which is attached to the container exclusively via the lateral inner surface. Here, a frictional connection is provided. On the other hand US 2010/0280414 A1 discloses a container in which a needle holder interacts with the outer surface of a cylinder by means of a form-fit or frictional connection and is thus attached to the container.
DE 101 02 054 discloses a vial with a predetermined breaking point which can be closed with a plug, which, however can also be attached to the vial only via the inner surface of the container.
Both containers are not suitable for applying viscous substances, because the joint between the container and the corresponding connecting elements cannot bear the forces occurring thereby.